Digital Clinical Hypnosis for Chronic Lower Back Pain

Overseen By Joy Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Psychotic disorders, Psychiatric hospitalization, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of digital hypnosis recordings for individuals with chronic lower back pain. Researchers aim to identify which audio recordings participants prefer and which most effectively reduce pain. Participant feedback will aid in developing a mobile app to make hypnosis treatment more accessible. Individuals who have experienced lower back pain for at least three months and feel it on most days may be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance pain management accessibility for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing hypnosis audio recordings, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that digital clinical hypnosis is safe for chronic lower back pain?

A previous study found hypnosis to be generally safe, with very few negative effects reported. Serious side effects are quite rare. Research has shown that clinical hypnosis can help reduce long-term pain and improve conditions like anxiety and depression. Notably, evidence for digital clinical hypnosis is mostly positive, indicating it is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital clinical hypnosis for chronic lower back pain because it offers a non-invasive and drug-free alternative to traditional treatments like medication and physical therapy. This approach uses online hypnosis recordings, making it easily accessible and convenient for patients to use at home. Unlike physical treatments that require in-person visits, digital hypnosis can be accessed anytime, potentially increasing adherence and effectiveness. By targeting the mind-body connection, this method may also help address the psychological aspects of chronic pain, offering a holistic approach to pain management.

What evidence suggests that digital clinical hypnosis is effective for chronic lower back pain?

Research has shown that digital clinical hypnosis can help manage chronic lower back pain. In this trial, participants in the treatment arm will have 8 weeks of access to online hypnosis recordings. Studies have found that combining hypnosis with pain education can reduce pain intensity and improve daily functioning. Other research supports hypnosis as an effective method for managing chronic pain, suggesting it can enhance well-being without medication. Accessing hypnosis through digital platforms increases the availability of this treatment for those in need. ^{1 4 6 7 8}

Who Is on the Research Team?

Mark Jensen, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic low back pain lasting more than 3 months, who rate their pain at least a 4 out of 10. Participants must speak English, have internet access, and own a device compatible with the digital therapeutic.

Inclusion Criteria

I have had chronic low back pain for more than 3 months.

You possess consistent internet access as revealed through self-reporting.

My average pain level in the past week was 4 or higher on a scale of 0 to 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive access to online hypnosis recordings for pain management

8 weeks

3 visits (virtual) at Baseline, 4 weeks, and 8 weeks

Waitlist Control

Participants are on a waitlist for 4 weeks before receiving access to hypnosis recordings

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Clinical Hypnosis

Trial Overview

The study tests different hypnosis audio recordings to see which are preferred by participants and most effective in reducing chronic low back pain. The goal is to create an app based on feedback that can help manage chronic pain.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

8 weeks of access to online hypnosis recordings

Group II: Waitlist Control Active Control 1 Intervention

4 weeks of waitlist (no access to recordings) and then 4 weeks of access to hypnosis recordings

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A survey of hypnosis clinicians revealed discrepancies between research evidence and actual clinical practice, particularly regarding the effectiveness of hypnosis for various conditions and the occurrence of adverse events during treatment.

The study suggests improvements in hypnosis training, including better monitoring of adverse events, enhanced methods for addressing trauma-related symptoms, and support for clinician competency development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Connections between Clinicians and Research in Hypnosis Practice: Strategies for Practice and Training. McKernan, LC., Walsh, EG.[2023]

The study involved 45 patients with chronic low back pain who participated in a pain control course that included education about pain and self-hypnosis, but neither component showed a significant difference in effectiveness on pain intensity or psychological measures.

While the treatment did not significantly reduce pain intensity, it led to meaningful improvements in coping strategies and psychological well-being, suggesting that teaching patients to manage their pain may be a more realistic goal than solely focusing on pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and self-hypnosis in the management of low back pain: a component analysis. Spinhoven, P., Linssen, AC.[2019]

Hypnosis is generally a safe treatment method, but adverse effects can occur during clinical and workshop settings, highlighting the need for enhanced safety measures.

The article identifies 9 categories of adverse events that can arise in hypnosis workshops and discusses factors that may prevent these incidents from being recognized or reported, emphasizing the importance of awareness and proactive modifications to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues in the detection of those suffering adverse effects in hypnosis training workshops. Kluft, RP.[2015]

Citations

1.

withpower.com

withpower.com/trial/phase-back-pain-9-2023-78c4a

Digital Clinical Hypnosis for Chronic Lower Back Pain

Digital Clinical Hypnosis is unique because it uses hypnosis, a mind-body technique, to help manage chronic lower back pain, potentially reducing pain intensity ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S152659001830124X

Hypnosis Enhances the Effects of Pain Education in ...

We hypothesized that patients with chronic low back pain who received PE with hypnosis would report greater improvements in pain intensity and disability ( ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9964474/

Chronic Low Back Pain: A Narrative Review of Recent ...

In clinical practice, the management of individuals with non-specific cLBP should combine non-pharmacological and pharmacological treatments.

4.

awspntest.apa.org

awspntest.apa.org/doi/10.1037/cns0000425

Use and benefits of a digital therapeutic for chronic pain ...

A growing body of research supports the potential of therapeutic hypnosis for helping individuals better manage their chronic pain. However, access to this ...

5.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03383-2

The effects of telehealth-delivered mindfulness meditation ...

Group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11390056/

Adjunctive use of hypnosis for clinical pain - PubMed Central

The benefits of adjunctive hypnosis are mostly uncertain, but it may help reduce chronic pain when combined with education.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0738399123004780

Using hypnosis in clinical practice for the management of ...

This study describes the barriers and facilitators to implementation of clinical hypnosis in chronic pain management practice as well as implementing an online ...

8.

apa.org

apa.org/monitor/2024/04/science-of-hypnosis

Uncovering the new science of clinical hypnosis

Clinical hypnosis has clear benefits in psychotherapy, improving outcomes in areas such as pain management, anxiety, depression, sleep, and more.